Galapagos halts CAR-T trial due to Parkinsonism case

Galapagos, a Belgium-based biotechnology company, has temporarily halted the enrollment of participants in its phase 1/2 clinical trial for a BCMA-directed CAR-T cell therapy, named GLPG5301, due to an adverse event. This event involved symptoms of Parkinsonism, a movement disorder associated with Parkinson's disease. The trial had initially started late last year, focusing on adults with relapsed or refractory multiple myeloma. The study aims to evaluate both the safety and efficacy of GLPG5301 and the feasibility of manufacturing the autologous cell therapy at the point of care using Galapagos' seven-day vein-to-vein process.

The adverse event that led to the pause is not unique to Galapagos' therapy. Similar incidents have been observed in recipients of other BCMA-directed CAR-T cell therapies developed by Bristol Myers Squibb (BMS) and Johnson & Johnson (J&J). For example, during the development of J&J’s Carvykti, cases of Parkinsonism were documented, resulting in the inclusion of Parkinsonism as a risk in the therapy’s black box warning. Conversely, BMS’ rival therapy, Abecma, does not include such a warning but does mention a grade 3 Parkinsonism adverse event.

Following the adverse event, Galapagos has carried out an extensive review. Speaking during an earnings call, Dr. Jeevan Shetty, the head of clinical development in oncology at Galapagos, mentioned that the biotech had not observed anything in the patient that differed from what has been reported in limited literature. The patient’s symptoms prompted the company to pause the study as a precautionary measure, allowing for a thorough investigation into the patient's history, characteristics, and external guidance on the matter. This careful examination led to the implementation of additional safety measures.

Dr. Shetty conveyed confidence in the continuation of the study, stating that Galapagos has already submitted a protocol amendment to the European Medicines Agency (EMA) in June and anticipates resuming recruitment shortly. Enhancements to the study protocol include reinforcing the neurological monitoring component and closely tracking patients' histories, which the company believes will mitigate future risks.

Despite the setback, Galapagos remains committed to pressing forward with the trial and plans to share the study’s data in 2025. The company’s resumed focus on patient safety and protocol adjustments reflects a cautious yet optimistic approach toward advancing its BCMA-directed CAR-T cell therapy for multiple myeloma patients.

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